Biotechnology, Genetic Engineering, and “GMOs:” Why all the Controversy?

Biotechnology, genetic engineering, and related techniques and technologies have been subject to controversy and misinformation. This document provides an overview based on information gathered from credible, fact-based sources.

Biotechnology, and the newer methods of genetic modification-genetic engineering and recombinant (r) deoxyribonucleic acid (DNA) techniques and technologies can be very useful in pursuing important improvements in food production and the food supply and doing so much more readily and effectively than previously possible. The techniques and technologies of genetic engineering can be used to:

Enhance production agriculture, in a number of ways

Ensure better crop harvests

Enhance the nutritive value of specific foods

Enhance food safety

Reduce the environmental impact of the food system

Reduce waste

Contribute to sustainability of the food system

Help meet the world’s increasing food supply needs

These techniques and technologies have been studied and reviewed by many health and science-based organizations. The National Academies of Sciences, Engineering and Medicine, in the United States, conveyed on the basis of a relatively recent evaluation that they did not find any differences that would implicate a higher risk to human health from genetically engineered foods than the non-genetically engineered counterparts.

The U.S. Food and Drug Administration requires labeling of products developed using biotechnology if there are pertinent material facts to convey—such as nutrient composition, presence of allergens that would not typically be expected with a specific food, or quality. In 2016, a bill (S. 764) was enacted, providing for a National Bioengineered Food Disclosure Standard.

Biotechnology, genetic engineering, and related techniques and technologies have been subject to controversy and misinformation. This document provides an overview based on information gathered from credible, fact-based sources.

The use of genetic modification techniques and technologies to enhance or produce food and ingredients, often referred to as biotechnology, genetic engineering (GE), or “GMOs,” has often been subject to controversy and misinformation. Some view biotechnology and genetic engineering as a threat to health, biodiversity, and the environment. Others believe the scientific advancements in the newer genetic modification capabilities have valuable benefits: helping to provide nutrition-related benefits, enhance food safety, ensure better harvests for farmers, reduce the environmental impact of the food system, and contribute to sustainability.

The National Academies of Sciences, Engineering, and Medicine (National Academies)—a private, nonprofit group of institutions that provides independent expert analysis and advice on some of the most pressing challenges facing the nation and the world—has conducted reviews and evaluations on this topic for several decades, and produced two recent analyses (NASEM 2016; 2017a,b). They reported that “the root of several of the views about biotechnology stems from differing world views about how uncertainty should be treated in decision-making, what types of risks should be considered in oversight, the role of technology in addressing problems of society, and who should have power, voice, and choice” (NASEM 2017b). They also said, “How important concerns about biotechnology are in comparison to the benefits provided depends not only on the interpretation of evidence, but also on an individual’s and social group’s perception of risk and technologies.”

This fact sheet was compiled to provide information gathered from credible, fact-based sources to give a high-level overview about biotechnology and genetic engineering as related to the food system.

What are biotechnology, genetic engineering and the like, and why are they used?

Biotechnology, genetic engineering, and recombinant (r) deoxyribonucleic acid (DNA) genetic modification methods are techniques that can be very useful in pursuing important improvements in food production and the food supply (e.g., enhancing the nutritional content of specific foods). These and other terms and their definitions are provided in the Appendix.

Biotechnology and genetic modification techniques have the potential to help meet the world’s increasing food supply needs in more efficient, economical, and sustainable ways, by minimizing the use of important resources like land, water, and other inputs, helping reduce waste, and in some cases saving lives through nutrient enhancement of foods.

Improvements include the introduction of beneficial traits in production agriculture, such as weed control. Other improvements include: beneficial traits in crops such as drought and insect resistance; cold, heat, and salt tolerance; capabilities for better nitrogen and phosphorous use, and enhanced carbon fixation; and resistance to viruses and other plant pathogens. Both conventional breeding and genetic engineering can be used to introduce some of these traits (e.g., insect resistance), while others are only achievable through genetic engineering (e.g., increased nutrient content above naturally occurring levels or introduction of nutrients in crops that were originally not good sources of the nutrient) (NASEM 2016).

In production of oil-producing crops, scientists are developing traits to reduce the susceptibility of the oil to rancidity (off colors, odors, or flavors). Other food-related applications include nutritional, food safety, and quality enhancement benefits. Examples are improved vitamin and fatty acid profiles, enhanced micronutrient content, reduced toxin levels, increased shelf life, and reduced produce bruising potential. Some nutrition-related improvements could address micronutrient and protein deficiencies that are prevalent in certain regions of the world. For example, modification of bananas, rice, cassava, and sweet potatoes is being pursued to address nutrient deficiencies in people in developing countries who have inadequate diets (NASEM 2016, 2017b).

The history of genetic modification dates back more than 10,000 years to when people began saving seeds for selective breeding. This and other classical genetic modification methods progressed to increasingly powerful, specific, and more controllable molecular and cellular techniques (IFT 2000; NASEM 2016). Along with the developments in new techniques and technologies, advances in food science-related research, multi-disciplinary research, and microbial and plant genome sequencing have helped further plant science and food science (Jez and others 2016; Selle and Barrangou 2015). This scientific progress is enabling complex food system improvements and allowing advancements to occur on a greater scale with increased speed and precision.

The National Academies (2016) reviewed the development of genetic engineering in crops, and the evolution of policies for crops and foods that have involved the use of these techniques. Genetic engineering began in the 1970s, as rDNA techniques were developed; application in plants drew on this and other developments, including those in plant tissue culture which occurred earlier (NASEM 2016).

The Academies reported (NASEM 2016) that soon after a publication in the 1970s described rDNA technology, concerns were expressed about the potential for unexpected biosafety risks and that this led to the development of biosafety principles for safe research practices, and research guidelines from the National Institutes of Health (NIH). A modified version of these research guidelines is still in effect. In the 1980s, some who had concerns about broader social and ethical issues as well as potential risks began criticizing and opposing genetic engineering. Opposition continued, from a variety of groups and interests, with other events such as the U.S. Supreme Court’s decision about the patentability of living, human-made organisms, and the development of rBST (a recombinant version of a naturally-occurring hormone—bovine somatotropin—that increases milk production in cows).

In the United States, a tomato with delayed softening and ripening traits, marketed in the 1990s, was the first plant developed with rDNA technology. Other rDNA-derived crops—virus-resistant squash, insect-resistant potato and corn, and herbicide-tolerant soybean and canola—were developed in the next couple of years. In 1999, a food processing enzyme (chymosin, used in cheesemaking) was able to be produced from a modified microorganism, allowing a purer, non-animal source (bacterial or fungal) than the traditional enzyme. This development led to use of the technology in producing other food-grade enzymes beneficial to food manufacturing and processing (e.g., lactase, which breaks down the milk sugar lactose; and alpha-amylase, which breaks down starch).

Another, more recent development is the establishment of “non-GMO” product recognition via a seal on product labeling. While the application and commercialization of genetic engineering innovation in the food system from a business perspective can be controversial, worthy of debate, and have policy considerations, the underlying science has endured the extensive rigor of the scientific method, including extensive academic peer-review concluding empirically in support of the science. The underlying science, however, is often confused with the decisions by companies about whether and, if so, how to apply and market the innovations made possible by the science. As a result, far-reaching policy decisions have occurred and activists have targeted the science, corporations, and government policies, rather than distinct applications of the science, thereby limiting the real potential of the science itself. This is despite the fact that science supports the conclusion that use of genetic engineering per se does not present any greater safety risk with foods than their non-genetically engineered counterparts.

A recent report of the International Service for the Acquisition of Agri-Biotech Applications (ISAAA 2016) noted that during the 20-year period of biotechnology crop commercialization between 1996 and 2015, biotechnology adoption has grown from five countries to 30 (with 19 developing and seven industrial countries planting “biotech” crops in 2016). Twenty-six countries have adopted biotech crops, and planted them in 2016; 12 of the countries are in the Americas, eight in Asia, four in Europe, and two are in Africa. The United States was in the lead in percentage of biotech crops planted in 2016, at 39% of the global total, followed by Brazil at 27%, Argentina (13%), Canada (6%), India (6%), Paraguay (2%), Pakistan (2%), China (2%), South Africa (1%), and Uruguay (1%) (ISAAA 2016). Eight of these top 10 countries, in percentage of biotech crops planted in 2016, are classified as developing countries. In addition to these data, the ISAAA also reported that adoption of biotechnology-derived crops has resulted in additional gain in farmer income, slowed biodiversity loss, saved some land acreage from ploughing and cultivation, reduced agriculture’s environmental footprint, and helped address sustainability, climate change, and poverty and hunger (ISAAA 2016).

What types of crops and foods developed with genetic engineering techniques are approved or on the market?

In 2016, the National Academies reported that 12 crops developed with genetic engineering techniques were available in several different countries. Soybean, maize, and canola with herbicide- and insect-resistant traits are grown, as well as, on a smaller scale, virus-resistant papaya, anti-browning apples and potatoes, and potatoes with reduced potential for formation of acrylamide (a chemical that can form from sugars and an amino acid in some foods during high-temperature cooking such as frying, baking, or roasting). Other products include eggplant, oilseed rape, and sugar beets. Some of these crops and foods have enhanced agronomic traits, others have enhanced nutrition and quality traits. The U.S. Food and Drug Administration recently approved a type of salmon that can grow and reach market weight faster than the non-genetically engineered farm-raised counterpart. Currently the salmon is farmed outside the United States. Other foods and ingredients (e.g., vanillin, stevia, saffron) produced by genetically engineered microorganisms (e.g., bacteria, yeast) via fermentation or from yeast-derived molecules have been commercialized (NASEM 2017b). Genetically engineered crops or plants are commonly used to produce foods such as corn chips, breakfast cereals, soy protein bars, corn syrup, cornstarch, corn oil, soybean oil, and canola oil, and food ingredients such as corn starch used in soups and sauces; corn syrup used as a sweetener; oils used in mayonnaise, salad dressings, breads, and snack foods; and sugar, from sugar beets, used in a variety of foods (FDA 2015; USDA 2016).

What types of genetically engineered crops and foods might we see in the future?

According to the National Academies, an area of development is the use of yeast and algae as alternatives to traditional animal sources for the fermentative production of foods and ingredients (in the creation of vegan products like vegan milk and cheese, for example). Other products on the horizon include mushrooms with a reduced-browning trait, additional insect-resistant crops, virus-resistant cassava, soybeans low in polyunsaturated fats, drought-tolerant maize, disease-resistant wheat, major staple crops with increased vitamin E, potato with modified starch and sugar content, crops with increased photosynthesis capability, yogurt with genetically engineered microorganisms, probiotics, and reduced-allergen goat’s milk (NASEM 2017b).

Regulation varies around the world, given the social, legal, political, and cultural differences among countries, and controversies surrounding the topic (NASEM 2016; 2017b). In the United States, a 2017 update of the U.S. Coordinated Framework for the Regulation of Biotechnology, established in 1986, describes the federal oversight ensuring safety of biotechnology products and protection of health and the environment.

The U.S. regulatory framework involves three federal agencies—the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and United States Department of Agriculture (USDA)—and their statutory authorities, regulations, and guidance documents. Regulation is on the basis of the intended use and characteristics of the product, and may involve more than one agency (NASEM 2016).

For example, within the Federal Insecticide, Fungicide, and Rodenticide Act, the EPA prevents and eliminates unreasonable adverse effects on the environment. Within the Federal Food, Drug, and Cosmetic Act, the FDA ensures the safety of human and animal food. As part of this, the agency maintains a voluntary premarket consultation process so that any issues associated with food from a new plant variety are resolved prior to commercialization. The USDA protects livestock from animal pest and disease risks and agricultural plants and agriculturally important natural resources from damage from organisms that pose plant pest or noxious weed risks. This includes ensuring that the U.S. commercial supply of meat, poultry, and egg products is safe and wholesome.

This review of GE crops is significantly more rigorous than that faced by new crops developed through traditional means. Because of this careful attention, new GE crops may be considered to offer a higher level of scrutiny than other crops.

Beyond federal regulation, international trade agreements (e.g., those overseen by the World Trade Organization [WTO]) and international standards address genetically engineered foods and products. For example, the Organisation for Economic Co-operation and Development (OECD) has guidelines relating to environmental safety, and the Codex Alimentarius Commission has principles for the risk analysis of foods derived from modern biotechnology, and guidelines for assessing the safety of foods derived from rDNA plants, microorganisms, and animals.

How are genetically engineered products assessed for safety and environmental risk?

Assessing food safety and environmental risks involves comparison of the genetically engineered product with its conventional food or ingredient counterpart, and the evaluation of intended and unintended effects or differences and their impacts. Risk assessment includes safety assessment and includes a variety of data which may include information related to the identification of any new or altered hazards, impact on nutritive and other composition, toxicity, and allergenicity. In regards to the environment, effects on non-target organisms, invasiveness or weediness, and potential for gene transfer to related species are considered.

The National Academies (NASEM 2016) conducted a detailed evaluation of comparisons between currently commercialized genetically engineered and non-genetically engineered foods in compositional analysis, acute and chronic animal-toxicity tests, long-term data on the health of livestock fed genetically engineered foods, and human epidemiological data. They concluded that no differences were found that implicate a higher risk to human health from these genetically engineeredfoods than those from the non-genetically engineeredcounterparts.

Their evaluation noted development in some situations of some problematic insect and weed resistance that would require integrated pest management strategies for sustainability in crops with insect- and herbicide-resistant traits. They also noted that gene flow from a GE crop to a wild related plant species occurred, but that no resultant adverse environmental effects were observed.

In regard to animal health, they reported that the large number of experimental studies and long-term data on livestock health before and after the introduction of genetically engineered crops showed that there were no adverse effects for animals consuming food from genetically engineered crops. And, they found little evidence connecting genetically engineered crops with adverse agronomic or environmental problems.

Additionally, six of the world’s other Academies of Sciences (in Brazil, China, India, Mexico, the Third World Academy of Sciences, and the Royal Society), and the American Medical Association, American Association for the Advancement of Science, Food Standards Australia New Zealand, and World Health Organization have made statements supporting the safety of the approved products of biotechnology.

The FDA requires labeling of products developed using biotechnology if there are pertinent material facts to convey—such as a nutritionally significant difference from the conventional counterpart, or differences in food quality. In 2016, a bill (S. 764) was enacted that amends the Agricultural Marketing Act of 1946 with a National Bioengineered Food Disclosure Standard. This Act, requires the USDA to establish mandatory labeling requirements on food packages in the form of text, symbol, or electronic or digital link for food products that contain genetic material modified through in vitro rDNA techniques in a way that could not happen through conventional breeding or which are not found in nature. The USDA has two years to develop the regulations for the labeling, and determine the amount of any biotechnology-derived ingredients in foods that would require labeling. When promulgated, the regulations would preempt state biotechnology labeling laws.

Another aspect of labeling is the complexity that arises with food or food components that are used in multiple foods, and use of ingredients (e.g., starch) from GE plant varieties (e.g., corn) in food. In addition, are the activities and practices implemented to segregate GE and non-GE crops that arise as a result of the organic and conventionally grown non-GE markets and need for product differentiation (USDA 2016). Many countries have mandatory GE labeling polices, and tolerance levels for GE material in organic or identity-preserved non-GE products (USDA 2016).

Monoculture, the planting of many acres of a single variety of a crop, exists with or without genetic engineering. A GE trait can be developed in many varieties of a crop, thereby reducing the impact of monoculture.

The scientific support for biotechnology and genetic engineering is substantial. Relatively recently, support was expressed by Nobel Laureates in a letter that spoke out against spearheaded opposition to biotechnological innovation. Of note was Golden Rice, a rice that had been genetically engineered to contain beta-carotene, which converts to vitamin A when consumed. Millions of people in Southeast Asia and Africa do not get enough of this vital nutrient; so, this genetically engineered rice has become the symbol of an idea—that genetically engineered crops can directly improve the lives of many undernourished poor.
The letter, which was signed by 123 Nobel Laureates of Chemistry, Economics, Literature, Medicine, Peace, and Physics, stated that: “Scientific and regulatory agencies around the world have repeatedly and consistently found crops and foods improved through biotechnology to be as safe as, if not safer than those derived from any other method of production. There has never been a single confirmed case of a negative health outcome for humans or animals from their consumption. Their environmental impacts have been shown repeatedly to be less damaging to the environment, and a boon to global biodiversity.” (Support Precision Agriculture)

A number of definitions relating to genetic modification were provided by the National Academies, including:

Biotechnology: “A number of methods other than selective breeding and sexually crossing of plants to endow new characteristics in organisms.” Biotechnology includes many techniques ranging from “recombinant (r) DNA technology” to more recently developed techniques.

Genome: “The complete sequence of the DNA in an organism.”

Genetic engineering: “The introduction or change of DNA, RNA, or proteins by human manipulation to effect a change in an organism’s genome or epigenome.” An epigenome “consists of the physical factors that affect the expression of genes without affecting the DNA sequence of the genome.”

GMOs: An acronym frequently used loosely to refer to the product (crop, food, or ingredient) of a change made via genetic engineering as opposed to one made via conventional means of genetic modification (e.g., selective breeding). The informal or unspecific use of this acronym may be misinforming or confusing (FDA 2016); the U.S. Food and Drug Administration considers genetic engineering to be more precise (FDA 2015).

Sampling of Viewpoints of Distinguished Stakeholders “.... molecular modification is the safest and most powerful technology we’ve ever developed for the daunting task of continuing to increase the amount of food for a growing population and doing it more sustainably.”
Nina V. Fedoroff, Eva Pugh Professor at the Pennsylvania State University and Distinguished Professor Emerita, King Abdullah University of Science and Technology (Saudia Arabia), Former Science and Technology Advisor to U.S. Secretary of State, Former President of the American Association for the Advancement of Science, National Medal of Science laureate in the field of biological Sciences

“There is an important place for genetic engineering efforts to promote agricultural development, reduce rural poverty, improve nutrition and ensure sustainable management of natural resources.”
Per Pinstrup-Anderson, Graduate School Professor and Professor Emeritus of Cornell University, World Food Prize laureate, Former Director General of the International Food Policy Research Institute

“I believe in science, in the social responsibility of scientists, and in the use of progress in science for humanity. It has been established beyond any reasonable doubt that plant biotechnology does not carry any technology-inherent risk.”
Ingo Potrykus, Scientist and co-inventor of Golden Rice, one of Top Living Contributors to Biotechnology by the peers of Scientist (2005), Most Influential Scientist (1995 – 2005) by the peers of Nature Biotechnology

“Scientific and regulatory agencies around the world have repeatedly and consistently found crops and foods improved through biotechnology to be as safe as, if not safer than those derived from any other method of production. There has never been a single confirmed case of a negative health outcome for humans or animals from their consumption. Their environmental impacts have been shown repeatedly to be less damaging to the environment, and a boon to global biodiversity.”
123 Nobel Laureates of Chemistry, Economics, Literature, Medicine, Peace, and Physics

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